BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1622891 · Received February 22, 2010

    Report

    Report Number
    1219702-2010-00001
    Event Type
    Other
    Date Received
    February 22, 2010
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Product Code
    BSB
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS PROBLEM CLEARLY OCCURRED BECAUSE OF USER NEGLIGENCE IN USING AN IV POLE THAT HAD A "CABLE TIE-DOWN POST" AND NOT USING THE SUPPLIED IV POLE. THE SYSTEM APPEARED TO HAVE BEEN DROPPED ONTO THE "CABLE TIE-DOWN POST". THE POST PIERCED THROUGH THE METAL FAN GUARD AND PREVENTED FAN FROM TURNING. CONSEQUENTLY, WITHOUT THE FAN TO KEEP THE INSIDE OF THE UNIT FROM OVERHEATING, THE UNIT OVER-HEATED. EVAL: WE RECEIVED THE UNIT ON NOV 16, 2009. WE EXAMINED THE UNIT VISUALLY AND FOUND: SOME OF THE INTERNAL WIRING HAD BEEN REMOVED AND TIE-WRAPPED TO THE POLE CLAMP HANDLE; A LOOSE COMPONENT COULD BE HEARD RATTLING AROUND WITHIN THE SYSTEM; LARGE QUANTITIES OF BLOOD AND SALINE OUTSIDE THE UNIT; ONE OF THE FEET WAS MISSING FROM THE BOTTOM OF THE UNIT; THERE WAS A LARGE HOLE IN ONE OF THE FAN GUARDS. THE SCREEN FROM THE GUARD WAS IMPEDING ANY MOVEMENT OF THE FAN, THE AIR INTAKE WAS NEAR TOTALLY OBSTRUCTED BY SALINE AND DUST; AND THERE WERE A NUMBER OF AREAS THAT WERE INDICATIVE OF IMPACT DAMAGE.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE NONE BSB BELMONT INSTRUMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1